Thyroid Awareness Week
15th – 21st October 2011

It's also Thyroid UK's 10th Anniversary!

We have some excellent projects this year, including the launch of the
Thyroid UK Web of Stories Channel

and our Government e-petition

click here to read all about our new projects

To read our Thyroid Awareness Week 2011
Press Release,
click here

7/10/2011

The Royal College of Physicians
update their Statement (Not Guidelines)

Thyroid UK was made aware today that the RCP updated their Statement.
We have checked and the only changes are:

· "…and should be treated with levothyroxine tablets, a synthetic form of the thyroid hormone thyroxine (also abbreviated to T4). Instead of "….and should be treated with thyroxine (T4) tablets."

· "There is no evidence to support the use of body fluids other than blood (eg urine, saliva) to test…." Instead of "There is no evidence to support the use of thyroid hormone testing in urine, saliva etc …."

· In the last statement they said, " …Armour thyroid…has not been scientifically proven to be of any benefit to patients…." but in the new statement, they say, "…Armour thyroid…has not been unequivocally proven to be of any benefit to patients…."

· "Sub-clinical hypothyroidism is defined as being present in a patient when the TSH is above the upper limit of the reference range (but usually less than 10mU/L) but Free T4 levels are within the reference range." Instead of "Sub-clinical hypothyroidism is defined as being present in a patient when the TSH is above the upper limit of the reference range but Free T4 levels are within the reference range."

The addition of "unequivocally" may be helpful to thyroid patients.
Click here for the full document

Forest Stop Shipping Armour to Europe

Thyroid UK was informed by Springfield Pharmacy that there were problems with obtaining Armour thyroid from pharmacists and that Forest were not going to ship to Europe any more.

We immediately telephoned Forest Pharmaceuticals Customer Service Department and were told that this was true but they wouldn’t give a reason and refused to put me through to anyone else in the organisation.

We therefore contacted the Food and Drug Administration (FDA):

Dear Sirs,

We have been informed by a member of the UK public that Armour thyroid is no longer going to be available in the UK.

I telephoned Forest Pharmaceuticals Customer Service Department and was told that this was true but she couldn’t give me any further information and refused to put me through to anyone else in the company.

She was extremely evasive and would not give any further information except to say that they were regulated by yourselves (which as a UK charity for thyroid health, we already knew).

 I got the impression that there had been a rule change somewhere and so I am writing to you to ask if you have any further information.

The UK NHS purchases a large amount of Armour thyroid for patients and the numbers of patients using Armour thyroid have increased year on year.  We therefore need some further information to inform both members of the public, the NHS and Government of something that will potentially cause ill health to members of the UK public.

 I look forward to hearing from you with either some further information on the regulation of Armour thyroid or perhaps some information that will enable Forest Pharmaceuticals to be more open and transparent with us.

Kind regards, Lyn Mynott, Chair/Chief Executive

We then received a response from the FDA:

Dear Lyn,

Thank you for contacting the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

The FDA regulates drugs which are manufactured and marketed in the United States.  However, the FDA cannot require drug makers to make drugs available.  Please understand that the drugs marketed in the U.S. must be reviewed and approved for safety and efficacy.  You may learn more about our regulatory process on the FDA website at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
SmallBusinessAssistance/ucm053131.htm.

Here is some background information.  The desiccated thyroid drug products, including Armour Thyroid, are on the market and available to consumers, even though they are not FDA-approved.  FDA has not ordered all unapproved thyroid products off the market.  There is no specific 'rule' regarding desiccated thyroid drug products.  Rather, FDA has urged all companies who market unapproved drug products, including thyroid products, to submit applications for approval.  FDA is concerned that drugs marketed without required FDA approval have never been submitted to rigorous scientific evaluation, and therefore may not meet required standards for safety, effectiveness, quality, and labeling.  Marketers of drug products in the U.S. have an obligation to the public to ensure through the FDA approval process that their products meet modern standards for safety, efficacy, quality, and labeling.   

As a policy matter we do not discuss potential, pending, or ongoing actions except with the firms and individuals who are the subject of those actions.  Information about enforcement actions against classes of unapproved drugs is posted on the FDA website.  Actions against unapproved drugs are made in accordance with the priorities discussed in FDA’s Compliance Policy Guide on Marketed Unapproved Drugs,
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM070290.pdf

For additional information regarding unapproved drugs, please access our unapproved drugs website at the following link:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
EnforcementActivitiesbyFDA/
SelectedEnforcementActionsonUnapprovedDrugs/default.htm

We hope this information is helpful.

Best regards,
Division of Drug Information LC
Center for Drug Evaluation and Research
Food and Drug Administration

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